Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure

NCT06511622 | Recruiting

• 1 other identifier: ARDS-Infectio
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections.

Conditions

ARDS

Keywords

ARDS; ECMO; Herpes viridae

Outcome Measures

Primary Outcomes (8)

• Herpes simplex reactivation

  semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage

  01/2019- 12/2025

• Cytomegalovirus reactivation

  as absolute copy number per milliliter of blood or bronchioalveolar lavage

  01/2019- 12/2025

• Epstein Barr virus reactivation

  absolute copy number per milliliter of blood or bronchioalveolar lavage

  01/2019- 12/2025

• B cells (CD19 positive)

  Absolute number per nanoliter and percentage of lymphocytes

  01/2019- 12/2025

• Natural killer cells Cells (CD16 pos)

  Absolute number per nanoliter and percentage of lymphocytes.

  01/2019- 12/2025

• T helper cells (CD4)

  Aabsolute number per nanoliter and percentage of lymphocytes

  01/2019- 12/2025

• Cytotoxic T cells (CD8)

  Absolute number per nanoliter and percentage of lymphocytes

  01/2019- 12/2025

• HLA-DR expression on monocytes

  in molecules per cell

  01/2019- 12/2025

Secondary Outcomes (18)

• Beginn weaning

  01/2019- 12/2025

• Extracorporeal membrane oxygenation duration

  01/2019- 12/2025

• Costs of treatment

  01/2019- 12/2025

• Pathogen persistence after guideline-compliant therapy (yes/no)

  01/2019- 12/2025

• Ventilator-associated pneumonia (yes/no)

  01/2019- 12/2025

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients who received intensive care treatment for acute respiratory distress syndrome on ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days.

You may qualify if:

• Male and female acute respiratory distress syndrome patients who had an immune status within 48 h of admission
• Patients who received intensive care treatment for acute respiratory distress syndrome ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days

You may not qualify if:

• None

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin

Berlin, 10117, Germany

RECRUITING

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 55 11 02; claudia.spies@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 22, 2024
• Study Start: July 10, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)